Biofarma set up a new Italian probiotic plant

Last 23rd January Biofarma started a new 16 million Euros production site dedicated to lactic ferment supplements. The operation was conducted in partnership with the Danish multinational company Christian Hansen. Biofarma is an Italian company located at Mereto di Tomba (Udine) specialized since 1987 in contract manufacturing of dietary supplements, medical devices, and cosmetics. Danish Christian Hansen is global bioscience company leader in the probiotics for food and pharmaceutical industry.

The new plant is over 4,000 square meters and is made of twelve production areas. An external space of 1,000 square meters is dedicated to the equipments that ensure good quality of the air in the production site, an element essential to preserve and guarantee the quality of the raw materials processed.

«Christan Hansen and Biofarma – states Germano Scarpa, Biofarma President – had been able to share their aims and to put together two different cultures and their manufacturing know-how. This has given birth to an innovative partnership in terms of technological economical and commercial vision».

«Our partnership is essential – says Christian Barker, Vice President, Health and Nutrition Division of Christian Hansen. – Our relation with Biofarma has been born ten years ago and has been consolidated thanks to Biofarma management’s ability to see solutions before obstacles, to commit resources, and to believe with us in the probiotic market».

Characteristics of the manufacturing site and production capacity

The new Biofarma pharmaceutical plant is a three floor building in order to optimize the probiotic mixing production line. All rooms are served by an air conditioning system to control and monitor the environmental conditions such as temperature and humidity. The air conditioning system is able to maintain the relative humidity of the packaging area at 50 % RH and that of primary production area below 25% RH. The pharmaceutical areas are dedicated to production and packaging of oral solid dosage forms such as capsules, tablets and bulk powders containing probiotics. When fully operational, the plant will produce more than 300 tons of product that equals to about 100 million units of finished product.

The mixing powder line is over the three floors to use gravity as only source of energy applied to the powder handling: the raw materials are loaded and sieved at the second floor, are mixed at the first floor and the mixture is discharged at the ground floor. The mixing step takes place in a 2000 litres mixer, capable of mixing 1200 kilograms batch of powder each time under a nitrogen inert atmosphere. The discharge takes place in a stainless steel bin with a capacity of 500 litres. On each floor a touch-screen PLC (Programmable Logic Controller) system controls the whole line and allows the operators to monitor and modify all the process parameters. Thanks to a pneumatic system the discharged mixture move directly from the bin to the lines where it can be tableted, encapsulated or packaged in aluminium sacks or stick-pack sachets.

Capsule and tablet production

Tablets are compressed by a high speed rotary tabletting machine, that can produce up to 300,000 tablets per hour. After the initial setup of the weight and hardness parameters, the machine allows the control of the compression force applied to each tablet during the compression phase. In addition, at predefined time points, tablet samples are taken at different compression stations and weighted. If weight or hardness of the samples differ from those set, the machine discards the non-compliant tablets and automatically adjusts the dosage and compression parameters.

Capsules are made by using an high speed continuous encapsulating machine that can produce up to 100,000 capsules per hour. The machine controls the production by taking a sample of the capsules, weighing it and checking the respect of the weight parameters set. In case of out-specification results the not conform capsules are rejected and the dosage parameters are adjusted to have all the capsules into the weight range set.

Tablets and capsules are dedusted and controlled by means of a metal detector to assure the absence of foreign bodies; after this step the dosage forms are packed in aluminium bags with desiccant sachets to guarantee optimal storage conditions before performing the final packaging operation in blister or tube with desiccant.

Monolab MB961,the blister machine used, can thermoform PVC, PVC/PVDC , TRIPLEX , ACLAR , PP, PET, ALU/ALU. The ALU/ALU blister packaging is performed under modified atmosphere (nitrogen) to maximize the barrier effects of the blister. The blistered product are monitored by a camera system that allows the discharge the non-compliant products. The blistering machine operates up to 60 cycles per minute. The bottle packaging line is composed by several stations: automatic bottle unsclamber, tablet/capsule counter, labeller, weight controller (dynamic scale in line), cartoning machine and case packer. The filling line allows a precise count of the tablets put into each bottle, checks the accuracy of the data variables printed on the bottle bottom and on the label, and weights each bottle. Each bottle out of the specification is signaled and eliminated at the end of the production line.

Packaging in stick-pack or in 5 kg bags

If the mixture has not to be tableted or encapsulated it goes directly from the bin to the packaging area where a pneumatic system load the semifinished product into a packaging machine that can package it into stick-pack sachets or aluminium bags that can contain a maximum weight of 5 kg. A 10 lane granules vertical packaging machine is used to package the mixture into stick-pack sachets. The packaging phase is monitored and controlled “in process” by a PLC and an external touch-screen. The whole mechanism is internal, so cleaning is easy and compliant to GMP requirements and FDA standards. The machine is high versatile in respect of size change. The movement is run entirely by brushless servomotors that allow to obtain high dosing precision, and careful sealing; the machine operates under modified atmosphere (nitrogen). From 1 to 10 grams of product can be packed with productivity up to 20,000 sticks per hour. A camera system monitors and ensures the correct coding of variable data.

Packaging in aluminium bags uses a vertical packaging machine for the production of cushion bags. The machine is equipped with PLC and touch screen and made of stainless steel and aluminium anodized with a special treatment that allows washing the entire surface with running water and specific sanitizing products. The process is carried out under nitrogen modified atmosphere. The packed bags are online checked by X-ray to monitor the absence of foreign bodies. A check weigher ensures the dosing strict accuracy.